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Clinical Trials: Cancer - Breast
IRB No. 14-129-6 (Dr. Biree Andemariam, PI): Sickle Cell Trait-related Blood Cell Adhesion as a Determinant of Disparate Cancer Treatment Outcomes
SPECIFIC AIMS The research objective of this proposal is to determine if blood cells from persons who are sickle cell trait carriers react adversely to standard chemotherapy compared to blood cells from persons without this genotype. African-American women have disparate breast cancer survival rates compared to white women that cannot be fully explained by either socio-economic or tumor marker expression differences. While sickle cell trait (SCT) is rare in the white population, nearly 10% of African-Americans carry SCT and most are unaware. Several case reports in the literature have described adverse reactions to systemically administered chemotherapy in African-Americans with SCT raising the possibility that chemotherapy-induced intravascular sickling may occur. Subsequent vaso-occlusion (overt or sub-clinical) may give rise to symptoms such as pain and nausea, or clinical signs such as unexplained anemia and renal insufficiency. These signs and symptoms may lead to treatment delays, dose-reductions and in some cases, cessation of therapy altogether--- all of which can impact efficacy and, most importantly, survival. We have previously shown that red blood cells (RBCs) from individuals with SCT are more adhesive to vascular endothelium than normal RBCs and that this adhesion is enhanced under physiologic stress conditions. We aim to compare the effect of chemotherapy on RBC adhesion to endothelial proteins in white women and in African-American women with and without SCT. The results are expected to lead to novel approaches to reverse disparities in cancer treatment outcomes among African-Americans. Our central hypothesis is that RBCs from African-American women with SCT are more adherent to vascular endothelium in the presence of chemotherapy than are healthy RBCs from both white and African-American women without SCT. To test the hypothesis, we will pursue the following two specific aims: Assess for baseline differences in RBC adhesion to endothelial proteins among white women as compared to African-American women– We will measure the change in quantity and strength of adhesive interactions between single RBCs and endothelial proteins. The influence of race and SCT-status will be examined. Test the in vitro effect of chemotherapy on RBC adhesion to endothelial proteins among white women as compared to African-American women – We will measure the in vitro effect of chemotherapy on single RBC adhesion to endothelial proteins. The influence of race and SCT-status will be examined.
IRB No. 15-027-2 (Dr. Susan Tannenbaum, PI): S1207, "Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neuNegative Breast Cancer."
Primary Objective: The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer. Secondary Objectives: a. To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population. b. To evaluate the safety, toxicities and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and compare it with standard adjuvant endocrine therapy plus placebo in this patient population. c. To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors. d. To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population. e. To collect specimens in order to evaluate biomarkers of therapeutic efficacy.